Methotrexate

Methotrexate Patient Decision Aid

Should I take methotrexate for my rheumatoid arthritis?

What is a                 Patient Decision Aid?


This decision aid gives you information about RA, the medications used to treat it, details about methotrexate (MTX) and some questions to help you think through what is important to you.




You have 4 options to choose from

Your Options

This decision aid should help you feel more confident about the reasons for your decision. When planning your treatment in the future, your doctor will find it useful to know these reasons too.

1. Continue

2. Start MTX

3. Discuss options other than MTX with your doctor

4. Defer your choice for now


Information about RA

Information About RA

RA is a disease where your body’s natural defense (immune) system is over active and can affect your whole body. It results in inflammation of the joint lining – particularly the hands, wrists and feet. This can affect you by causing general feelings of sickness like fatigue, fever, or loss of appetite in addition to swelling, pain and stiffness of the joints. Together these symptoms reduce your ability or interest to do important activities at home, work and leisure. It is usually a chronic disease which means that it typically cannot be cured but needs regular treatment over many years to control symptoms and minimize complications.

If no treatment is chosen the symptoms of RA will vary but continue for years. In addition, most people will have at least some damage to the joints. This can lead to disability and may even shorten your life. Recent research suggests people with RA, especially if poorly controlled, have a higher risk for heart attack and stroke.


Treatments for RA

Goals of RA Treatment

The main goals of RA treatment are to suppress joint inflammation, reduce pain and swelling, and slow or prevent joint damage.

To reach these goals, there are three types of medication used: Non-steroidal anti-inflammatory drugs (NSAIDs), prednisone and disease modifying anti-rheumatic drugs (DMARD). Often all three types are prescribed together to control joint inflammation. DMARDs are usually started soon after the diagnosis of RA and continued for as long as the disease continues.

The table below shows these three types of medication and where MTX fits. The cost of MTX is about $20/month and it is covered by most insurance programs.

Information about MTX Therapy

Information about MTX

MTX has been used to treat RA since 1976 and is one of the most effective and commonly used drugs. It is known as a disease-modifying anti-rheumatic drug (DMARD) because it not only decreases the pain and swelling of arthritis, but also can reduce damage to joints, which is a cause of disability. It works by hindering the growth of hyper active inflammatory cells.

MTX is available in pills or as an injection in the skin. It is prescribed at a dose between 7.5-25 mg taken one time per week. To reduce side effects, 1 mg of folic acid is taken daily. RA begins to improve about 3-6 weeks after starting MTX, although the full benefit may not be seen for up to 6 months.


Understanding the Benefits

One goal of taking MTX is to improve your RA symptoms. If you improve you should expect less pain and stiffness. Gripping, reaching and daily activities should also be easier. You also may have more interest in taking on physical activity.

You have about a 65% chance of your RA symptoms improving if you choose to take MTX. Another way to look at this is to see what happens if 100 patients start MTX.

The outcomes of 100 patients treated with MTX

Some patients improve more than others with a new treatment. After starting MTX about 50% of patients will have major improvement and about 15% will have their RA completely suppressed.

Improvements from MTX are usually sustained, which allows many patients to continue on it for 5 years or more.


How RA Joint Damage Progresses Without Treatment

How RA joint damage progresses without treatment 

The diagram below shows the course that RA may follow if no treatment is used. The top pictures show what the progression looks like on the outside, while the bottom pictures show what is happening to the joints under the skin.

One of the major problems of RA is that joint damage can begin in the first year of the disease and build up over time if the disease is not controlled. These pictures show how swelling of the joint lining can break down bone and cause “erosions” to form where the support ligaments attach. This weakens the joint and over time allows the joints to move out of line and deform.


How RA Joint Damage Is Slowed with MTX Treatment

One benefit of MTX is its power to slow further joint damage. Research has shown MTX can reduce the rate of RA joint damage in most patients by about 85%.

Another way to look at this is to consider:

  • If you take no treatment you will have the expected amount of added joint damage (100%).
  • If you take MTX less damage will occur – about 15% of what would have been expected.


Understanding Side Effects

Understanding             Side Effects 

All drugs have the potential for benefit and harm. In the next few pages we have listed the most common, as well as some less common but serious, side effects. Part of being informed is having an idea of how often these events happen. This booklet is not meant to replace talking with your medical provider. Rather, its goal is to inform you and support your decision making.

Conception

If you or your spouse conceives a child while you are taking MTX, miscarriage or fetal birth defects can occur. Therefore, sexually active men and women using MTX must use a medically approved form of birth control. MTX does not necessarily reduce a woman’s ability to conceive during treatment or in the future.

Quesiness

Common minor side effects are to feel a little tired or queasy the day you take MTX. Sometimes this can be severe, though it usually improves with time or can be reduced with minor changes in the treatment program such as: reducing the dose, taking the medication at bedtime or taking folinic acid pills 6 hours after the MTX. When you start MTX, you should talk with your doctor if you have side effects. Adjusting the MTX dose will often minimize side effects.

Low Blood Counts

People with RA often have anemia (low levels of red blood cells). This can be caused by the disease, stomach ulcers or other effects from drugs. Sometimes MTX can reduce blood levels. This can cause fatigue, bleeding or increased risk of infection.

To help prevent the side effects from low blood levels, you must take regular blood tests. For many people getting these blood tests is the most difficult part of taking MTX. The American College of Rheumatology recommends all persons taking MTX for RA have blood tests every 4-12 weeks as long as they continue on MTX.

Other Side Effects

Occasionally MTX can cause other side effects, like mouth sores, slight hair thinning, or sun sensitivity. If you think these are a problem for you, talk with your doctor.

Patients with RA, particularly those with highly active disease, may be at a higher risk (up to 3x) of lymphoma. Whether MTX contributes to this risk has not been established.


Reducing Serious Side Effects

Reducing                 Serious Side Effects 

Suggestions for the safe monitoring of MTX have been made by the American College of Rheumatology. While this will not prevent all problems, if you follow these guidelines you will likely detect problems earlier. This should help your doctor to make adjustments and reduce serious side effects.

MTX Safety Monitoring Plan

1. Before starting:    check blood and a chest x-ray

2. After starting:   check blood every 4 - 12 weeks.

3. See doctor regularly for exams.

Serious Infection

Serious Infection 

Because MTX reduces the hyperactive immune system in RA, it can also reduce your ability to fight off serious infections like pneumonia, kidney infections, etc. 

(When we refer to serious infections, we mean infections severe enough that you would need to be admitted to the hospital for one or more days to receive antibiotics through the vein and/or other care like IV fluids and oxygen.)

If you are > 65 years old, have other diseases such as diabetes, or take prednisone, your risk may be higher. 

If you are young and healthy your risk may be lower. MTX should not be taken by persons with HIV (Human Immunodeficiency Virus).

If you choose to take MTX you have an added chance of about 2% each year of having a serious infection. 

Another way to look at this is to see what happens if 100 patients start MTX.

The outcomes of 100 patients treated with MTX for 1 year

Liver Scarring

Liver Scarring

Drugs that are broken down by the liver can cause liver irritation. Sometimes this can lead to permanent liver problems. Some minor liver irritation is common with MTX, however long term studies have shown that serious liver scarring (cirrhosis) is rare.

If you choose to take MTX you have about a 1/1000 chance over 5 years of having serious liver scarring. 

Another way to look at this is to see what happens if 1000 patients start MTX.


The outcomes of 1000 patients treated with MTX for 5 years


Reducing Liver Scarring

Advice for Reducing Serious Liver Scarring

1.  Do safety monitoring laboratories as directed to follow blood counts. 

2.  Notify your doctor of all drugs you take.

3.  Avoid daily alcohol use.

4.  If you have hepatitis B or C do not take MTX


The American College of Rheumatology recommends all persons taking MTX for RA have safety blood tests every 4-12 weeks as long as they continue on MTX. These tests can detect early liver irritation. 

  • If monitoring blood tests are normal, there is a high level of assurance that MTX can be continued safely.
  • If you do have patterns of high liver tests you will most likely not feel anything abnormal. In that case you and your rheumatologist may choose to adjust or stop the MTX or have a liver biopsy to check if the high liver tests are due to MTX related scarring. 

If MTX is continued in patients with established scarring this could cause liver failure and death.


Lung Scarring

Lung Scarring 

Lung scarring is another rare, but serious side effect of MTX. This usually causes a sudden onset asthma-like reaction or a dry cough. If the drug is stopped promptly and treatment provided, people usually fully recover. However in some cases permanent scarring can occur. When this happens you might be short of breath with daily activities or minor exertion and could require oxygen therapy. There is no effective treatment for this type of advanced scarring.

If you choose to take MTX you have about a 1-2% chance each year of having lung scarring. Another way to look at this is to see what happens if 100 patients start MTX. This is shown in 2 different ways on the following page.

The outcomes of 100 patients treated with MTX for 1 year


Sorting it Out

Sorting It Out

This is a good time to think back about what you know about your options and what is most important to you. While you might think the choice you face is simply whether or not to take MTX, there are at least 5 options available.


How do you make hard decisions?

How do you make hard decisions?

When making hard decisions it is sometimes helpful to see how others went about choosing what was best for them. 

Consider the people below. Do any of them approach decision making like you?


Weighing the Facts

Earlier we outlined possible benefits and side effects from taking MTX.

Possible Benefits

Possible Benefits

  •   Less pain, stiffness and fatigue
  •   Improve physical function
  •   Reduce progression of joint damage
  •   Prevent complications of active RA
  •   Use less prednisone (steroids)


Possible Side Effects

Possible Side Effects

  •   Pregnancy planning and birth defects
  •   Mild fatigue or queasiness after MTX dose
  •   Serious infection
  •   Liver irritation or scarring
  •   Lung scarring

Are any of these especially important to you?

What matters most to Me? 

What Matters Most to Me 

Of the risks and benefits, are you clear what are most important to you?  While is it possible that you will not experience any of the side effects in this brochure, it is important to think about how you would feel if you did.

The table below lists some of the benefits and risks  of therapy.  In your mind rate how much each of these matter to you if they were to occur.


Moving Towards a Decision 

Moving Towards a Decision 

Now that you know more about MTX and have considered what is most important to you about the decision, are you leaning towards a particular choice? 

Some people find listing the pros and cons makes the decision clearer. Try creating a table like the one below and filling it out to sort out what matters most to you.


Conclusion

Conclusion

MTX is a powerful medicine that can help control RA, but there are risks in taking it. Because RA is a chronic disease, you may need to take MTX for years. This will mean that if you choose to take MTX, you will have to be committed to taking the medicine and monitoring its safety. Fortunately rheumatologists have decades of experience using MTX in RA, and it can be used safely in most people.

The decision to take MTX may mean that you have to make some changes to your lifestyle. As described above, you may feel tired and dizzy on the day of treatment and you should be prepared to make time to get your blood work done. Additional changes you may need to make are to reduce your sun exposure and alcohol intake, and quit smoking if you are able.


Reflecting on your decision

Am I moving towards a good decision? 

As you work towards making a decision about MTX, decide whether these statements are true for you

  • I know the options
  • I am informed about the benefits and harms of treatment.
  • The doctor gave me a chance to be involved in the decision.
  • I feel an informed choice was made.
  • I will have the support I need to get, take and monitor the safety of the new medicine.

If most or all of these statements are true for you, you are on your way to a good decision. 

If not, you may want to talk further with your doctor, nurse, family or other important support persons.


Check what you know about MTX with these questions



Where can I get more information?


Facts and numbers behind this decision aid

Sources of data:

  1. Donahue KE. Systematic Review: Comparative Effectiveness and Harms of Disease-Modifying Medications for Rheumatoid Arthritis. Annals Intern Med 2008;148:124-134.
  2. Bathon J. A comparison of etanercept and MTX in patients with early rheumatoid arthritis. N Engl J Med. 2000 Nov 30;343:1586-93. 
  3. Walker AM. Determinants of serious liver disease among patients receiving low-dose methotrexate for rheumatoid arthritis. Arthritis Rheum. 1993;36:329-35. 
  4. Carroll GJ. Incidence, prevalence and possible risk factors for pneumonitis in patients with rheumatoid arthritis receiving MTX. J Rheumatol. 1994;21:51-4. 
  5. Katchamart W, Trudeau J, Phumethum V, Bombardier C. Methotrexate monotherapy versus methotrexate combination therapy with non-biologic disease modifying anti-rheumatic drugs for rheumatoid arthritis. Cochrane Database Syst Rev. 2010 Apr 14;(4):CD008495.
  6. Singh JA et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis.  Arthritis Care Res (Hoboken). 2012 May;64(5):625-39.
  7. Clinical experts such as rheumatology physicians and nurses when published sources were absent or conflicting. 

Reading level: SMOG: 9.9

Content Editor: Richard W. Martin, M.D., M.A. Professor of Medicine, Rheumatology. Michigan State University, College of Human Medicine. Author disclosure: No conflict to report.


Co-investigators: P Gallagher BS, A Head MD, A Eggebeen MD, J Birmingham MD.  

Technical and creative consultants:  R. Jelsema, Brennan Martin, Josh Quinn.

Acknowledgments:  The development of this patient decision was inspired by the work of a number influential basic and applied decision scientists.  We wish to acknowledge: Annette O’Connor PhD, John Wennberg, MD, Margaret Holmes-Rovner, PhD, Hillary Bekker, PhD, Gerd Giggerenzer, PhD, Timothy Wilson, PhD, Peter Ubel, MD, Adrian Edwards, MD and Glyn Elwyn, MD.


Funding:  This decision aid was developed, evaluated and published solely with private funds.  


Year of last update or review: 2013.


Copyright  2013 

West Michigan Rheumatology, PLLC 

1155 East Paris Ave. SE, Suite #100
Grand Rapids, MI 49546 

616-459-8088

www.mi-arthritis.com


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